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NCT Number: NCT02820909

Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit

The femoral approach is the preferred vascular access for the set-up of emergency catheters in severely traumatized patient. This location combines simplicity and speed of installation, it allows the simultaneous set-up of arterial and venous catheters, and is a provider of few complications and failures.

The ultrasound guidance has greatly reduced installation times, failures and complications related to the set-up of central venous catheter. This was amply demonstrated in the internal jugular and subclavian site outside of extreme emergency situations (Fragou M et al 2011, Farrell J et al 1997, Karakistos et al 2006). The benefit of ultrasound guidance for the set-up of arterial and venous catheters in the femoral emergency has not been evaluated in terms of reduction in complications.

Then the main objective of this study is to demonstrate that the ultrasound guidance reduces early complications related to the set-up of arterial and venous catheters in the femoral emergency, among severely traumatized patient compared to the reference anatomical technique.

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Key information

Conditions

Severely Traumatized Patients in Emergency Wards Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of intensive care unit, Hospital Edouard Herriot- Hospices Civils de Lyon, 5 Place d'Arsonval

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult
  • Included in intensive care unit for severe trauma
  • Need for implementation of femoral arterial and venous catheters in accordance with the practices of the service.
  • Agreed to participate
  • Affiliation to national security

Exclusion criteria

  • Contraindication to the set-up of vascular access in femoral position (femoral Scarpa wound, aortic dissection)
  • Local infection
  • Hypothermia <32°C
  • Need for implementation of arterial catheter only
  • Need for implementation of venous catheter only

Treatment and study plan

venous and arterial catheter set-up using ultrasound guidance

Procedure

The insertion of the venous and arterial catheter will be done using ultrasound guidance. Vein and artery will be identified in cross section. In case of anatomical difficulties, complications of puncture with anatomical landmarks, or if installation time is greater than > 5 minutes, an intra-osseous catheter will be put in place to avoid delaying of treatment according to the current practice of the intensive care unit.

Anatomical guidance.

Procedure

In the anatomical group, catheter will be inserted using, as it is currently done in intensive care unit, anatomic landmarks. If catheterization according to the anatomic method is considered too difficult (> 3 punctures), a conversion to ultrasound guidance will be done.

In case of anatomical difficulties, complications of puncture with anatomical landmarks, or if installation time is greater than > 5 minutes, an intra-osseous catheter will be put in place to avoid delaying of treatment according to the current practice of the intensive care unit.

Primary outcomes

  1. Proportion of complications 1 week after catheter set-up.

    Time frame: 1 week.

    The primary end point is the proportion of patients with a complication one week after arterial and venous catheter set-up.

    Complications will be defined as follows:

    • mechanical immediate complications (hematoma, bleeding, dysfunction or non-function of the catheter, or aberrant course subcutaneous catheter)
    • Mechanical complications remote installation catheters (arteriovenous fistula, pseudoaneurysm), thrombotic complications.

    Vascular assessment will be conducted by an angiologist, using doppler ultrasound of the femoral vessels. Assessment will be made blind from the use of ultrasound guidance during installation.

Secondary outcomes

  1. Cannulation time between the 2 groups

    Time frame: the day of surgery (Day 1)

    Comparison of cannulation mean time between the ultrasound guidance group and anatomical guidance group.

    Cannulation time is defined as the time in seconds, from the first contact between the needle and the skin, and when the two guide wires are inserted into the vessels (artery and vein).

  2. total catheter set-up time between the 2 groups

    Time frame: the day of intervention (Day 1)

    Comparison of total catheter set-up mean time between the ultrasound guidance group and anatomical guidance group.

    Total exposure time of the catheter is defined as the time, in seconds, from the first contact between the needle and the skin, and when the dressing is applied to both catheters in place and fixed.

  3. Success of cannulation

    Time frame: the day of intervention (Day 1)

    Comparison of cannulation success proportion at first attempt between the 2 groups. Cannulation at first attempt is a success if the needle is inserted at first attempt. A cannulation is defined as successful if the needle is inserted without resistance

  4. Number of cannulation attempt

    Time frame: the day of intervention (Day 1)

    Comparison of the number of attempt before cannulation success in between the 2 groups. Conversion to ultrasound guidance in the anatomical guidance group will be taken into account.

  5. Number of puncture attempt

    Time frame: day of intervention (Day 1)

    Comparison of the total number of puncture between the 2 groups. A puncture test is defined as the passage of the needle without changing direction or without new movement in depth. Each needle withdrawal, followed by a new movement to deep planes or redirection of the needle is regarded as a new test, with or without skin puncture. The number of tests will be evaluated by an observer.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Interest of the Ultrasound Guidance for the Laying of Femoral Arterial and Venous Catheters in Intensive Care Unit: A Controlled, Randomized Trial: The ECHOGUIDE Study

Acronym: ECHOGUIDE

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 1, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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